BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053603 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04346
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    November 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION IS CONSIDERED STILL OPEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DETERMINED TO HAVE INTERMITTENT OUT-OF-RANGE SHOCK IMPEDANCE, OCCASIONALLY EXCEEDING 125 OHMS SHOCK IMPEDANCE. AT IMPLANT, THIS LEAD WAS AT 80 OHMS SHOCK IMPEDANCE. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE SOURCE OF THE INTERMITTENT RISE IN IMPEDANCE WAS NOT KNOWN AT THE TIME OF THIS INITIAL REPORT. TROUBLESHOOTING WAS TO BE DONE. THERE WERE NO OBSERVED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT WAS EVALUATED IN THE CLINIC AND THE SHOCK IMPEDANCE MEASUREMENT WAS 123 OHMS. THE PHYSICIAN HAS ORDERED THAT THE PATIENT CONTINUES TO BE MONITORED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 4470| 0180| E110